Texas Christian University

IACUC Protocol Application 1

Texas Christian University

Institutional Animal Care and Use Committee

Animal Use Protocol Application

(August 2016)

Protocols are reviewed by the full IACUC at a convened meeting. A majority of a quorum of the committee is required for certain action, including protocol approval. The committee Chair acts as, or selects a committee member to act as, the primary reviewer, who take responsibility for presenting the protocol at the full committee meeting. The Attending Veterinarian and the Chair also perform a "pre-review" prior to distributing the protocols to the IACUC. If a member has a real or perceived conflict of interest, they may not contribute to the quorum, deliberate or vote on that project.

Instructions:

Use the most recent version of this form to apply for IACUC approval of any new use of animals for teaching or research, or for renewal of a previously IACUC-approved animal use. Current versions may be found at
Consult with the Attending Veterinarian, or his or her designee, during protocol development.
Answer each section of this form completely and accurately.
After completing this form:
send one (1) hard copy of this application (minus this instruction page), signed by the Principal Investigator to:

Egeenee Q. Daniels, DVM()

UNTHSC Director, Laboratory Animal Medicine

3500 Camp Bowie Blvd.

Fort Worth, TX 76107-2699

e-mail one copy of the form to the IACUC at .

Dr. Daniels will send the signed copy of the application to the IACUC Chairperson. If you should receive the signed copy from Dr. Daniels please forward it to:

Lorrie Branson, J.D.

3101D Sadler Hall

TCU Box 297024

Fort Worth, TX 76129

Upon return receipt of protocol application approved by IACUC, forward copies of the signed Committee Action Form (last page of this application) to the appropriate sponsoring agency.
The Chairperson of the IACUC will notify the Investigator, the Attending Veterinarian, and the Associate Provost as to the Committee action. Approved applications will be assigned a protocol number which must be referenced on: (1) All internal correspondence regarding the negotiated animal use, (2) Purchase order requisitions for the animals, and (3) Identification cards required for all of the animals.

Expiration: All protocols expire three years from the date of approval, if not earlier, and all are subject to Annual Continuing Review (after the first and second year of research/instructional activity). Within 30 days following the first and second anniversaries of the initial IACUC approval (the date referenced on the Committee Action Form of this application), an Annual Animal Protocol Review application must be submitted to the IACUC. If activity is desired to be continued beyond the third anniversary, a new Animal Use Protocol Application must be submitted for full IACUC review.

Amendment: Following initial approval of a protocol, proposed changes in personnel, funding agency, species, numbers of animals, and/or procedures should be submitted to the IACUC using the Animal Use Protocol Amendment application form.

Texas Christian University

Institutional Animal and Use Committee

Animal Use Protocol Application

AssignedProtocol #:______(For IACUC use only)

1. Principal Investigator/Project Director
Name:
Department:
TCU Box:
Office Telephone:

2. Student Researcher (if applicable):

Name:______Department:______

Address:______

Telephone: Office (_____)______

3. Other Collaborators:

Name:______Department:______

Project title or course name/number:

______

5. Funding source: ______Grant #______Account #______

6. Peer Review: ______Complete__ Pending __

7. Animal locations:

Housing:______Laboratory:______

Overnight __ Day use only __ Overnight __ Day use only __

8. Principal Investigator assurances. Signify by providing handwritten initial in each box.

__ I have a working knowledge of the PHS “Guide for the Care and Use of Laboratory Animals” and the USDA “Title 9 Animal Welfare Act” and its revisions.

__ The proposed work does not unnecessarily duplicate previous experiments, based on the following type of literature search:______.

__ All personnel involved in this project have been trained in the procedure to be used. A letter documenting this training has been sent to the IACUC.

__ I and all personnel have read any pertinent safety information, IACUC requirements, and security procedures (these procedures are found in the Vivarium).

__ I shall be responsible for maintaining records of all animals and the procedures carried out.

NOTE:Items 9-21 on the following pages should be answered for each species of animal to be used. If several species are involved, please duplicate the pages as necessary.

9. Animals Species:______Strain/Stock:______

Source:______USDA Approved Vendor: Yes __ No __

Duration of project (in years):______

Maximum number of animals to be housed at any one time:______

Estimated number per year:______

Total through course of project:______

10. Procedures performed on animals: In the space provided, give a brief layman’s description of the procedures that would be performed on animals in this project. Provide page number of continuation if needed.NOTE: The protocol application will not be approved unless sufficient effort has been put into describing the project in layman’s language.

11. USDA Classification of animal use (See Appendix A)

Please provide information for each year of the project.

Project Period*Number of Animals by Category

------

From (mo/yr)To (mo/yr)BCDE

------

*Include total anticipated period of project funding and animal use. Anticipated use of animals more than three years beyond approval date should be included, even though new IACUC approval will be required.

12. Are there special requirements for maintaining animals: Yes __ No __

If you answered yes, indicate the requirements below, such as caging type, bedding, type of water and dietary requirements. If you answered no, animals are to be maintained according to the standard operating procedures of the animal facility.

Other special instructions for animal care staff:

13. Instructions for treatment and disposition of animals (check ALL applicable circles):

IllnessDeathPest Control

------

__ Call investigator__ Call investigator__ None

__ Treat __ Necropsy __ Veterinarian’s Option

__ Terminate __ Bag for disposal __ Pyrethrum

14. Is the species wild or exotic? Yes __ No __

15. Invasive procedures

(Other than blood collection, catheterization, intubation, etc.)? Yes __ No __

If yes, will the procedure be done under anesthesia? Yes __ No __

If yes, describe the anesthesia to be used including dose and route of administration. If no, explain in detail why anesthesia will not be employed:

Individual responsible for post-anesthesia recovery: ______

16. Restraint

(Including, but not limited to chairs, slings, tethers, stanchions, and cages): Yes __ No __

If you answered yes, please answer a-e below:

a. Method:______

b. Duration:______

c. Frequency:______

d. Frequency of observation during restraint:______

e. Person responsible for observation:______

17. Surgery: Survival __ Multiple __ Terminal __ None __

a. Location (building/room) of surgical suite:______

b. Surgical procedure(s):______

c. Description of procedure(s):

d. Will anesthetics, analgesics, or tranquilizers be used? Yes __ No __

DrugDose (mg/kg)RouteTimes/DayHours/Day

------

e. Describe the post-operative care (survival procedures only):

f. Where are the animals held post-operatively?:______

g. Person responsible for postoperative observation:______

h. Will neuromuscular blocking agents be used? Yes __ No __

DrugDose (mg/kg)RouteTimes/DayHours/Day

------

i. How and by whom will the animal be monitored?

j. Under what circumstances will incremental doses of anesthetics/analgesics be administered?

k. If neuromuscular blocking agents are being used without general anesthesia, provide justification:

18. Intervention for pain or distress: analgesia __ euthanasia __ other ______

What interventions are withheld?

analgesia __ euthanasia __ other______

Circumstances under which interventions are to be used:

as recommended by Veterinarian ___

other (describe) ___

19. Disposition of animals (check all that apply):

euthanized __ other (explain) ___

Person(s) performing the euthanasia:______

Describe method(s). For drugs, give name, route, and dose:

Death assured by:______

20. Hazards to personnel (if applicable):

Radioisotope______

Carcinogen______

Biohazard______

Other______

21. Personnel

NamePosition

------

22. Will body fluids or tissue from these animals be utilized by other investigators:

Yes __ No __ If yes, explain.

23. Will controlled substances be utilized:

Yes __No __

If yes, please initial the following Statement of Assurance:

I am responsible for procurement, storage, administration, and record keeping for all controlled substances.

Initialed ______

24. Summary and Judicious Use of Animals:

On separate pages, attach an expanded summary to describe your work to the UCACU&IB. Please include the following:

Objective and significance of the project/course, including the probable benefits of this work to human and/or animal health, the advancement of knowledge, or the good of society.
A detailed description of the procedures to which the animals will be subjected.
Your reason for selecting the species and justification of number of animals used. Are other animals, especially lower species, suitable for these studies?
Describe your experience with the proposed animal model and manipulation.

-Do not submit a grant proposal, abstract, teaching syllabus, or reprint in place ofthe summary statement. Use language appropriate for a scientist outside your field. Append additional sheets as needed.

-Outside review of scientific and/or educational content of the protocol application may be necessary if no peer review is complete or planned (q.v., item 5, page 1), particularly if the animal use falls under USDA category 3 or 4. If this is the case, a more detailed summary will be required for item 23 (see IACUC Chairperson for instructions).

25. Written Narrative for Alternative to Painful Procedures (Policy # 12)

The PI must provide a written narrative of the sources consulted to determine whether or not alternatives exist to procedures which may cause pain or distress. Consideration of alternatives to each procedure which may cause pain or distress must state sources consulted, such as Medline, Index Medicus, Biological Abstracts, Current Research Information Service (CRIS), and the Animal Welfare Information Center (AWIC).

The minimal written narrative should include: the databases searched or other sources consulted, the date of the search and the years covered by the search, and the key words and/or search strategy used by the PI when considering alternatives or descriptions of other methods and sources used to determine that no alternatives were available to the painful or distressful procedure. The narrative should be such that the IACUC can readily assess whether the search topics were appropriate and whether the search was sufficiently thorough.

Please write this section in separate page(s) and add it to the end of your protocol. As a heading, use:

Policy # 12.

Principal Investigator Assurance

As Principal Investigator, I am aware that I have the ultimate responsibility, on a day-to-day basis, for the proper care and treatment of the laboratory animals. I agree to adhere to all federal, state and local laws and regulations governing the use of animals in teaching and research. I further assure the Texas Christian University Institutional Animal Care and Use Committee that the minimal number of animals will be used for the project and that every possible step will be taken to minimize stress or pain to the animals. I have carefully considered and concluded that no reasonable alternatives to the use of animals could be applied to this project, and that this project is not an unnecessary duplication of any previously published work.

I will submit appropriate annual review forms for this project, and obtain formal approval of the Committee prior to implementation of any changes in this protocol.

______

Principal Investigator/Course Director Date

______

Student Investigator (if applicable) Date

The Texas Christian University Department of Laboratory Animal Medicine and Animal Care Facility can satisfy the animal housing and maintenance requirements of this protocol. Where used, the type and amount of analgesic, anesthetic, or tranquilizing drugs above are appropriate by current professional standards, for relieve pain and/or distress. The methods of euthanasia are compatible with the recommendations of the AVMA guidelines on euthanasia (JAVMA, June 2013).

______

Egeenee Q. Daniels, DVM. Date

Director, Laboratory Animal Medicine

======

IACUC Action

___ Approved

___ Not approved

Comments: ______

______

IACUC Member SignatureDate

Committee Action

Texas Christian University

Institutional Animal Care and Use Committee

Principal Investigator/Project Director

Name:______Department:______

Phone: (____)______

Protocol number assignment: ______

StudentInvestigator (if applicable)

Name:______Department:______

Phone: (____)______

Project Title or course name/number: ______

___ The project conforms to the PHS policy on the protection of animals, and the activity is approved.

___ Under the special conditions outlined by the Texas Christian University Institutional Animal Care and Use Committee and the Principal Investigator (see attachment), the project conforms to the PHS policy on the protection of animals, and the activity is approved.

___ The project does not conform to the PHS policy on the protection of animals, and the activity is disapproved (see attachment).

______

Chairperson, Institutional Animal Care and Use Committee Date

Texas Christian University

APPENDIX A: